510(k) · Cleared
ClearedGaleo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo F 014 Model 115 487 Galeo HF 018
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DQX Wire, Guide, Catheter
Cleared on Jan 8, 1999 as substantially equivalent to K973494 (Guidant Corp., 1997) and 1 other predicate after a 193-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Jan 8, 1999
- Review
- 193 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913353 (1991). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK913353 Vascular Guide WireAdvanced Cardiovascular Systems, Inc. · 1991
- 2 generations backK971815 Asc Balance Middleweight Guide WireGuidant Corp. · 1997
- 1 generation backK973494 HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs…Guidant Corp. · 1997
- This deviceK982272 Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014…Biotronik, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK090193 Conductor Coronary GuidewireConcert Medical, LLC · 2009
- Descendant · cites it directly · 0 of its ownK042373 Galeo Focus Guide WireBiotronik, Inc. · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913353 | Vascular Guide Wire | Advanced Cardiovascular Systems, Inc. | 1991 | — |
| −2 | K971815 | Asc Balance Middleweight Guide Wire | Guidant Corp. | 1997 | — |
| −1 | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque… | Guidant Corp. | 1997 | — |
| 0 (this device) | K982272 | Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model… | Biotronik, Inc. | 1999 | — |
| +1 | K090193 | Conductor Coronary Guidewire | Concert Medical, LLC | 2009 | — |
| +1 | K042373 | Galeo Focus Guide Wire | Biotronik, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973494 | HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance…Summary page 2…s The Galeo guide wires are functionally equivalent to market-released guide wires. In specific, the materials used and design are similar to the Guidant ACS Hi-Torque (K973494, Dec. 12, 1997) series with the exception of the coating of the distal coil region. This coating is similar between the Galeo ser… | 1997 |
| * | K961917 | Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX)Summary page 2…Dec. 12, 1997) series with the exception of the coating of the distal coil region. This coating is similar between the Galeo series and the Medtronic Mustang guide wire (K961917, Nov. 20, 1996). BIOTRONIK June 26, 1998 11 13 < BEALTH o 4 %, Ry o SERVICE NS S, » 3 'y C DEPARTMENT OF HEA… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K090193 (Concert Medical, LLC, 2009) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K973494.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
Galeo Guidewires are intended for use in vascular interventional procedures to facilitate the placement of catheters within the coronary arteries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982272 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982272: Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo F 014 Model 115 487 Galeo HF 018.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982272
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026